The US Court of Appeals for the Federal Circuit has addressed the use of objective indicia of non-obviousness in the context of an inter partes reexamination. In Leo Pharma. Prods., Ltd. v. Rea,1 the court reversed a decision by the US Patent and Trademark Office Board of Patent Appeals and Interferences (the Board) and held that the Board erred in finding that a pharmaceutical composition using a combination of ingredients found in prior art was “obvious to try” and in failing to give the proper weight to objective indicia of non-obviousness.

This case arose from an inter partes reexamination of Leo Pharmaceutical’s US Patent No. 6,753,013 (the '013 patent), which claims a pharmaceutical composition for the topical treatment of such skin conditions as psoriasis, comprising three components: a vitamin D analog, a corticosteroid and a solvent. The claimed invention is further limited to a composition that is “storage stable and non-aqueous.”

Of primary importance in this case is the fact that the '013 patent identified and solved a key problem that had previously prevented successful combination of vitamin D and corticosteroids into a single composition for more effective pharmaceutical treatment. Combining the two components was attempted in the prior art, but differing pH levels caused the vitamin D analogs to degrade quickly, making the compositions unworkable or ineffective. While the prior art arguably disclosed formulations containing vitamin D and corticosteroids, none of these references identified the stability problem or offered an effective solution for combining vitamin D and corticosteroid components into a “storage stable” composition. The '013 patent, however, identifies this issue and discloses a set of solvents including polyoxypropylene 15 stearyl ether (POP-15-SE) which solve the storage stability problem.

During reexamination, the Board found that it would have been obvious to a skilled artisan to combine the ingredients in the '013 patent because they were disclosed in the prior art, and that this was a case of simply “picking and choosing” among known components. The Board also rejected Leo Pharmaceutical’s objective indicia of non-obviousness, determining that the favorable results of combining the patented ingredients was not surprising because each of the ingredients had been disclosed in the prior art.Citing KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Board concluded that the reason for using the disclosed ingredients in the prior art references did not need to be the same reason that the '013 patent used those ingredients, even though the '013 patent employed the solvent at issue for a different purpose than the prior art: to create a “storage stable” composition.

The Federal Circuit held that the Board’s construction of “storage stable” was impermissibly narrow, but declined to adopt an alternative construction as the construction was not determinate of the obviousness issue. Next, the Federal Circuit addressed the Board’s application of the law of obviousness to the underlying findings of fact in the case. The Federal Circuit noted that only “substantial evidence” is required to support the Board’s factual findings, while the question of obviousness is reviewed de novo. In this case, although no material facts were in dispute, the Federal Circuit disagreed with the Board’s analysis and application of the law, holding that Leo Pharmaceutical established that the Board failed to meet the “substantial evidence” standard.

Rejecting the Board’s finding that the claimed composition would be obvious to try, based on the prior art, the Federal Circuit gave great weight to Leo Pharmaceutical’s recognition of the storage stability problem afflicting the prior art, indicating that the identification of this problem may itself be valuable enough to render the '013 patent non-obvious. Given that the stability problem was not identified in prior art, the Federal Circuit rejected the Board’s application of KSR Int’l Co. v. Teleflex Inc.,and its subsequent finding that Leo Pharmaceutical simply chose among a finite set of possible solutions. The obvious to try analysis used in KSR did not apply in this case because Leo Pharmaceutical was the first to identify the storage stability problem, thus a known set of solutions did not exist.

In contrast to KSR, the Federal Circuit noted that the prior art here consistently taught away from the combination of vitamin D and corticosteroids in a single formulation, a fact that would deter a skilled artisan from pursuing the composition disclosed in the '013 patent. Thus, Leo Pharmaceutical did not simply pursue known and predictable solutions to an identified market need as suggested in KSR, but, rather, it disclosed both the storage stability problem and a solution to that problem in the '013 patent. The Federal Circuit additionally cited the elapsed time between the most recent relevant prior art and the '013 patent—more than a decade—as evidence that the claimed invention was not obvious to try.

The Federal Circuit also took issue with the Board’s conclusion that a strong case of obviousness outweighed evidence of the invention’s advantages in this case. Instead, the Federal Circuit determined that the objective indicia presented a compelling case of non-obviousness and that the Board’s determination was colored by hindsight. The Federal Circuit cited the unexpected results of Leo Pharmaceutical’s testing as an objective indication of non-obviousness, as well as the commercial success of its Talconex® ointment and FDA approval for the drug. The Federal Circuit reiterated that the evidence of a long-felt need for the formulation embodied in the '013 patent indicates that the solution discovered by Leo Pharmaceutical was not obvious.

Accordingly, the Federal Circuit reversed the Board’s obviousness finding, holding that in this case, the sum of the objective indicia are the most probative evidence of non-obviousness.


1. Leo Pharma. Prods., Ltd. v. Rea, No. 2012-1520 (Fed. Cir. Aug. 12, 2013) (Rader, J.).